Recall Z-1838-2017— Smith & Nephew, Inc.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-03-15, terminated 2018-07-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone. Reason: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming.
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-15
- Terminated
- 2018-07-10
- Firm location
- Mansfield, MA, United States
Product description
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Reason for recall
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Data sourced from openFDA. This site is unofficial and independent of the FDA.